Quality Lead
Key Responsibilities:
Audit Management – Host client audits and provide support for external inspections.
Quality Systems Oversight – Maintain, update, and ensure compliance with QMS policies.
Deviation Handling – Review and approve deviation investigations, ensuring proper resolution and documentation.
CAPA Management – Oversee corrective and preventive actions, ensuring effectiveness.
Regulatory Compliance – Ensure all quality processes align with local and global regulations.
Stakeholder Collaboration – Work closely with MI, operations, and client service teams.
Risk Management & Continuous Improvement – Identify potential risks, escalate concerns, and recommend corrective measures.
Committee Participation – Support regional and global quality committees.
Regional Quality Oversight – Serve as the primary quality contact for Japan, with potential for expanded responsibilities.
Administrative Support – Assist with documentation, reporting, and other quality-related tasks.
Required Qualifications:
Native Japanese speaker with strong English proficiency.
Experience hosting audits in a regulated industry.
In-depth knowledge of QMS, ideally with experience in electronic quality management systems (eQMS).
Extensive background in managing deviations and CAPAs, with authority to approve actions.
Strong organizational and communication skills, with the ability to manage quality-related challenges independently.
Previous experience in a pharmaceutical, medical device, or other regulated healthcare-related industry.